Keywords

Adverse Events, Patient safety, Clinical Trials, Regulatory agencies

Review on Adverse events reporting system

Adverse events are nothing but any adverse change in health that occurs while the patient is under treatment with some medication [1-4]. Clinical trials plays major role to identify the adverse events or adverse drug reactions by conducting in different cohorts of subjects. These clinical trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and health authority / ethics committee approval is granted in the country where the clinical trial to be conducted [5-8]. Pharmacovigilance deals with the study of detection and prevention of adverse effects particularly in case of long term and short term side effects of drugs.

Regulatory agencies will monitor and concentrate on capturing the data regarding adverse events. They mainly focus on the following data [9-12]:

• To improve patient safety

• To keep proper records of efficacy

• Providing the optimal information to the end-users by conducting the awareness programs

• Finding out new information about hazards associated with drugs.

• Examine changes in Benefits and Risks

• Detecting unknown hazards of drugs which happened previously

Clinical trials are mainly carryout by doctors and sponsored by the investigators. Those who conduct the clinical trials should be reported to the sponsors if any adverse event happened at the earliest [13-17]. If any serious adverse event identified, it should be reported within 24hours via case report forms (CRF), eCRF, or SAE forms [18,19].

Adverse events reporting system process is followed as, collecting the data from various sources like literature, spontaneous data etc. Then the collected adverse event data should be captured in databases [20]. Medical review has to be conducted on the captured case data. Once the review process has been completed then the result of case should be reported to the regulatory agencies.

Notification to the Regulatory Agencies:

• Unexpected serious adverse drug reactions to be submitted to the national regulatory authority within 15 days, if there should arise an occurrence of any life-threatening or death within 7 days it should be reported to regulatory authorities [21-23].

• The case safety reports also known as individual case submission reports for both sorts of early and after approval periods associated to the adverse drug reactions and adverse event reports [24].

There should be minimum criteria for reporting the adverse events such as:

• An identifiable patient – Age, gender, initials, date of birth, name or contact number of the particular patient. [25]

• A suspect medicinal product

• An identifiable reporting source

• Any one adverse event

Regulatory agencies mainly review the captured case date to find out either the drug is useful or harmful, to decide that the drug should be released or not, to keep the drug in the market or to withdraw it [26-28]. Every adverse event reported to pharmaceutical industry or regulatory agencies during the Pharmacovigilance process is known as the case study. Case report form and eCRF are used in clinical trials to report the data of patients to sponsor pharmaceutical companies by the physician [29,30].

Drug adverse events investigation and analysis is one of the principal objectives of any clinical trial, Pharmacovigilance science or medication safety depends vigorously on vital methodologies and operational advances that can be applied to any therapeutic areas [31-33]. Adverse event reporting system is done throughout the shelf life period of the pharmaceutical product or device or both before and after approval to examine and analyse its safety profile.

Analyses of ADEs typically concentrate on events surrounding the patient, the prescribing employees, the pharmacy employees, the administering employees, and also the selection of drug, and indeed several ADEs are associated with such procedural issues. These issues typically begin with the assumption that the drug as such has been approved for safe use within the marketplace in accordance with the approved directions. However, the main reason of a patient’s ADE might lie in the design of the randomized controlled trials (RCTs) that supported the approval of that drug for marketing [35].

Adverse drug events are major causes of morbidity in developed countries, however the medicine involved in these events are trialled and approved on the premise of randomized controlled trials (RCTs), considered the study design which will produce the most effective evidence. Though the main target on adverse drug events has been mainly on processes and outcomes related to the utilization of those approved drugs, attention must be directed to the manner during which the RCT study design is structured [14,24,36]. The implementation of controls to realize internal validity in RCTs is also the very controls that reduce external validity, and contribute to the degree of adverse drug events related to the release of a new drug to the wider patient population. An examination of those controls, and also the effects they can have on patient safety, underscore the importance of knowing regarding how the clinical trials of a drug are undertaken, instead of relying only on the recorded outcomes.

As the majority of recent medications are probably to be prescribed to older patients who have one or more comorbidities additionally to that targeted by a new drug and as the RCTs of those drugs typically under-represent the elderly and exclude patients with multiple comorbidities, timely assessment of drug safety signals is essential. It is unlikely that regulatory jurisdictions will undertake a reassessment of safety issues for drugs that are already approved [37]. Instead, reliance has been placed on adverse drug event reporting systems. Such systems have a very low reporting rate, and most adverse drug events remain unreported, to the eventual cost to patients and healthcare systems. This makes it essential for near real-time systems that can pick up safety signals as they occur, so that modifications to the product information (or removal of the drug) can be implemented.

Conclusion

Adverse drug reactions or adverse events are major clinical problems and to avoid this “Adverse events reporting system” should be maintained regularly. Patients or subjects, doctors, sponsors (Pharmaceutical industries or investigators), and Pharmacovigilance plays major role in the Adverse event reporting system. The reporting system would be completely monitored by the respective regulatory agencies to enhance the drug safety by conducting awareness programs to the patients, doctors, and Pharmaceutical industries.